King & Spalding today announced that Eva Temkin, Acting Director for Policy at the U.S. Food and Drug Administration’s Office of Therapeutic Biologics and Biosimilars from 2019 to 2021, has joined the firm as a partner on the FDA & Life Sciences team in the Washington, D.C., office.
In her position at FDA, Temkin led the Biosimilars Action Plan, the agency’s roadmap for building a competitive market for innovator biologics and biosimilars, and was responsible for policy development related to a wide range of issues touching therapeutic biological products and biosimilars, from review and approval of biologics license applications to exclusivity and life-cycle management considerations. Additionally, as Associate Chief Counsel at the FDA’s Office of Chief Counsel, Eva provided strategic counseling to FDA regulators on a wide range of complex biomedical-product issues and legislative initiatives.
“Eva is uniquely qualified to help clients navigate the complex landscape of the dynamic and evolving therapeutic biologics industry, which is often not well-understood by industry, investors, and other interested parties,” said Mark Brown, the Chair of the firm’s FDA & Life Sciences team. “Eva is one of very few lawyers with policy insight into the upper levels of FDA, and continues our 40-year tradition of attracting the very best lawyers from the Agency. Eva’s arrival will immediately and significantly complement offerings we can make to clients in this area.”
Temkin joined FDA in 2013 and held a variety of roles prior to her latest one, including senior regulatory counsel at the Office of Therapeutic Biologics and Biosimilars; senior policy advisor at the Office of New Drug Policy, in the Center for Drug Evaluation and Research; and Associate Chief Counsel in the Office of the Chief Counsel.
“Eva’s addition to the firm brings a powerful new level of regulatory knowledge to our award-winning practices and enhances our client services,” added Zach Fardon, who leads King & Spalding’s Government Matters practice, which includes our FDA team.
Temkin earned her undergraduate degree from the University of Michigan and her JD from New York University School of Law, where she was the Law and Economics Fellow (merit-based full-tuition award) and editor of the NYU Annual Survey of American Law. She clerked for Judge John Gleeson on the U.S. District Court for the Eastern District of New York and then worked for several years in private practice, focusing on complex commercial litigation and administrative law matters.
“I’m thrilled to be joining King & Spalding’s extremely impressive bench of life sciences practitioners,” Temkin said. “I look forward to helping life sciences companies navigate challenging regulatory waters, and also to working with my colleagues on related government investigations, policy advocacy, disputes, and investment matters.”
